Kornimate/medical-research-clean huggingface dataset:
evaluation of a genetically determined personalized approach in prescribing biologically active substances in patients with elevated blood homocysteine levels.

Conditions: Hyperhomocysteinemia

Summary: the clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. hyperhomocysteinemia (hhcy) is a risk factor for cardiovascular diseases (cvd), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. the trial aims to reduce plasma homocysteine levels to normal values (\ 15 µmol/l) and ldl cholesterol levels (≥1.4 mmol/l), without taking any substances that could influence homocysteine levels for at least one month prior. the trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results.


Eligibility criteria:
inclusion criteria: * increased homocysteine level above 15 µmol/l; * increased ldl level \>=1.4 mmol/l.; * absence of taking medications or any other products that may affect homocysteine levels in the blood for at least 1 month before enrollment in the study; exclusion criteria: * individual intolerance to the components of the substance; * pregnancy or breastfeeding; * severe concomitant disease requiring constant monitoring (estimated survival less than 1 year); * taking dietary supplements or medications containing one of the components: dietary supplements for at least 3 months before inclusion in the study.

Keywords: hyperhomocysteinemia cardiovascular diseases bioactive substances genetically-determined approach nutrigenomics
a study to assess efficacy and safety of filgotinib in active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this is a multicenter, phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active psoriatic arthritis (psa) who have an inadequate response or are intolerant to conventional disease-modifying therapy. a total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. the screening visit will occur within 28 days before study drug administration. at day 1 (baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. the study is concluded with a follow-up period lasting until 4 weeks after the last dose. consequently, each subject will stay in the study for a maximum of 24 weeks (from screening visit to follow-up visit).


Eligibility criteria:
key inclusion criteria: * male or female subjects who are ≥18 years of age, on the day of signing informed consent. * diagnosis of psoriatic arthritis meeting classification criteria for psoriatic arthritis (caspar) * have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count \[sjc\]) and ≥5 tender joints (from a 68 tender joint count \[tjc\]) at screening and baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint). * have had a history of documented plaque psoriasis or currently active plaque psoriasis * if using cdmard therapy, subjects must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline. * if using non-drug therapies (including physical therapies), thse should be kept sable during screening * male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol key exclusion criteria: * use of jak inhibitors, investigational or approved, at any time, including filgotinib; * prior use of more than one tnf inhibitor, at any time. * use of oral steroids at a dose \>10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline; * any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening; * use of more than 1 nsaid or cyclooxygenase-2 (cox-2) inhibitor. * have undergone surgical treatment for psoriatic arthritis including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening * presence of very poor functional status or unable to perform self-care. * administration of a live or attenuated vaccine within 12 weeks prior to baseline
neural mechanism underlying social cognition in depressive patients

Conditions: Depression

Summary: in the project, investigators plan to test difference of social cognition between depressive patients and healthy individuals and the brain activation underlying the difference to further understand the neural mechanism of depressive disorder.


Eligibility criteria:
inclusion criteria: * age range between 18 and 60 * education experience above high school * score for hamilton's depression scale \>=17 * diagnosis of depression through scid exclusion criteria: * undergoing electric shock treatment in 3 months * excluding those who with bipolar disorder * excluding those who with postpartum depression * excluding those who with hysteria
an animated home-based physical exercise program as a treatment option for patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this pilot study is to investigate feasibility and patients´ assessment using an animated home-based exercise program (software wii-fit of the nintendo wii game console) for patients with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * patients fulfilling the 1987 and 2010 american college of rheumatology (acr) criteria for rheumatoid arthritis * disease activity (patients' global assessment, ptga) \< 30 mm under therapy with a biological dmard according to label exclusion criteria: * epilepsy * flare of ra * a previous use of a wii console for more than 5 hours

Keywords: physical exercises physical therapy wii game console patients perspective
randomized study of radiofrequency- vs. cryo-ablation for typical isthmus-dependent atrial flutter

Conditions: Atrial Flutter

Summary: this randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: the (standard) radiofrequency (rf) ablation technique and the cryo-ablation technique regarding the acute and long term efficacy and safety.

this randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: the (standard) radiofrequency (rf) ablation technique and the cryo-ablation technique. the rf ablation of typical atrial flutter has become a standard approach with very high curing rates and low complication incidence. however, ablation with rf is painful since the underlying cardiac tissue heats up (up to 70-80°c inside the tissue) and especially the target of ablation in typical atrial flutter, the so-called cavo-tricuspid isthmus, is a very pain-receptive area. cryo-ablation, which destroys tissue by freezing it down to -80 to -90°c, is thought to be less painful or even painless with the same efficacy than rf ablation. the acute and long term (6 months follow-up, non-invasive) efficacy and safety is the combined endpoint.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * documented atrial flutter which is most probably typical isthmus dependent atrial flutter * informed written consent exclusion criteria: * prior ablation for atrial flutter * concomitant arrhythmia which is treated during the same ablation procedure * prior maze operation * contra indication for catheterization * physical or psychiatric disorder making participation in the study impossible * pregnancy * prior participation in the study * participation in another study
safety and efficacy of idp-118 in the treatment of plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the objective of the study is to evaluate the safety and efficacy of a topical lotion.

the objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

Eligibility criteria:
key inclusion criteria: * male or female, of any race, at least 18 years of age (inclusive). * freely provides both verbal and written informed consent. * has an area of plaque psoriasis appropriate for topical treatment that covers a bsa of at least 3%, but no more than 12%. the face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation. * is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * has a clinical diagnosis of psoriasis at the baseline visit with an iga score of 3 or 4. (the face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment). key exclusion criteria: * has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator. * presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator. * presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. * is pregnant, nursing an infant, or planning a pregnancy during the study period. * has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
real-world experience of patients treated for musculoskeletal injuries with sam in routine care

Conditions: Musculoskeletal Injury; Pain, Chronic; Pain, Acute; Sport Injury; Soft Tissue Injuries; Arm Injury; Back Pain; Tendon Injuries; Muscle Injury

Summary: the purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function and quality of life), and information on healthcare provider ordering the therapy and general workflow. low-intensity continuous ultrasound (licus) is a bio regenerative technology used when normal rehabilitation is insufficient, applied with a wearable device (sam, zetroz systems llc) for daily use. the treatment provides long-duration ultrasound for approximately four hours. the objective of this study is to examine the real-world outcome data on symptoms improvement and return to function using sam during routine care.

zetroz's sam ultrasound device is a portable and wearable medical device which, when applied to various areas of the body, applies low intensity therapeutic ultrasound to deep tissues. the sam device is currently used by a broad range of athletic trainers (ats) in the united states to assist in the rehabilitation of injured athletes. the purpose of this this study is to examine the real-world outcome data on symptoms improvement and return to function using sam during routine care. this includes understanding utilization of the treatment (how often and how much time), how the treatment helps patients (rehabilitation and recovery), and information on sam treatment augmenting conservative therapies.

Eligibility criteria:
inclusion criteria: * work-related musculoskeletal injuries with limited improvement under traditional therapies exclusion criteria: * healthy participant

Keywords: continuous ultrasound sustained acoustic medicine musculoskeletal injuries low intensity contiguous ultrasound pain soft tissue injury
normobaric hyperoxia combined with reperfusion for acute ischemic stroke

Conditions: Stroke, Acute

Summary: nbo is a nonpharmacological measure of neuroprotection. the purpose of our study is to evaluate the safety and efficiency of nbo（normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. looking for more clinical evidence for the ischemic stroke patients who will be treated with nbo in the future.


Eligibility criteria:
inclusion criteria: * male or female, age≥18 and ≤ 80; * suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ica or the m1-segment of the mca; * acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization; * patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra; * nihss score≥6分 * alberta stroke program early ct score (aspects) of 7-10 on non-contrast ct; * informed consent obtained; exclusion criteria: * rapid improvement in neurological status to an nihss \< 6 or evidence of vessel recanalization prior to randomization; * seizures at stroke onset; * intracranial hemorrhage; * systolic pressure greater than 185 mm hg or diastolic pressure greater than 110 mm hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits; * symptoms rapidly improving; * symptoms suggestive of subarachnoid hemorrhage, even if ct scan was normal; * platelet count of less than 100,000 per cubic millimeter; * ct showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere); * severe hepatic or renal dysfunction; * active and chronic obstructive pulmonary disease or acute respiratory distress syndrome; * \>3 l/min oxygen required to maintain peripheral arterial oxygen saturation (sao2)﹥95% as per current stroke management guidelines; * medically unstable; * inability to obtain informed consent; * life expectancy\<90 days; * pregnant or breast-feeding women; * unwilling to be followed up or poor compliance for treatment; * patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial; * evidence of intracranial tumor; * baseline blood glucose of \ 400 mg/dl (22.20 mmol);

Keywords: normobaric hyperoxia; acute ischemic stroke; vascular recanalization; endovascular treatment; reperfusion therapy
phase ii study to evaluate the efficacy of amg 317

Conditions: Asthma

Summary: a multi-center, randomized, placebo, multi-dose study to evaluate the efficacy of amg 317 compared with placebo as measured by change in asthma control questionnaire (acq) symptom scores from baseline to week 12.


Eligibility criteria:
inclusion criteria: * males or females 18 to 65 years of age at the time of screening * baseline percent of predicted fev1 ≥ 50% to ≤ 80% at screening * at least 12% reversibility over baseline fev1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months * inhaled corticosteroid (ics) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. stable ics dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. must have used ics for at least the last 3 consecutive months before screening * if receiving allergen immunotherapy, a stable dose for \> 3 months before screening and anticipated to remain stable for the duration of the study * positive to skin prick or rast * ongoing asthma symptoms with acq score at screening and baseline ≥ 1.5 points * nonsmoker or ex-smoker with \< 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago exclusion criteria: * acute asthma exacerbation requiring emergency room (er) treatment or hospitalization within 3 months * history of endotracheal intubation for asthma-related exacerbation within 3 years of screening * respiratory illness within 4 weeks of screening * history of chronic obstructive pulmonary disease (copd) or other chronic pulmonary condition other than asthma * received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit. * leukotriene antagonists within 2 weeks before first run-in visit * oral or parenteral corticosteroids within 6 weeks before first run-in visit * live/attenuated vaccinations within 4 weeks of screening or during the study * any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)

Keywords: asthma allergy il-13 il-4 il-4r
effect of phenylephrine versus norepinephrine on venous return

Conditions: Arterial Hypotension

Summary: induction of general anesthesia often induces a decrease in the mean arterial blood pressure (map) caused by arterial and venous dilatation. fluid administration is conventionally used to increase the patient's total blood volume, but is often associated with multiple adverse events such as postoperative edema. arterial hypotension can also be treated by vasopressor agents such as norepinephrine and phenylephrine which mainly increase the blood pressure by arterial vasoconstriction. compared to phenylephrine, norepinephrine has a shorter half-life (2 - 3 minutes) and improves the map by increase in cardiac contractility. in a recent study at our department it was demonstrated that besides arterial vasoconstriction, phenylephrine also improves venous return and cardiac output by venous vasoconstriction. the aim of this study is to compare the hemodynamic effects of both vasopressor agents in patients undergoing deep inferior epigastric perforators (diep) flap surgery. if significant differences between both agents are demonstrated, these findings can provide an important basis for future recommendations.

in consecutive patients scheduled for diep flap surgery, all hemodynamic and respiratory variables are recorded electronically for subsequent off line analysis. a systolic blood pressure of minimal 100 mmhg will be maintained during surgery by optimization of the cardiac preload and titrated norepinephrine (1.5 µg/kg/h) or phenylephrine (15 µg/kg/h) administration. cardiac preload optimization will be based on pulse pressure variation (ppv) measurement, which is calculated by pulse contour analysis of the radial arterial pressure curve. following the international goal-directed fluid therapy guidelines, plasmalyte will be administrated if the ppv\>11%. the tricuspid annular plane systolic excursion (tapse) will be measured by transthoracic echocardiography (tte) to evaluate the inotropic effect of norepinephrine and phenylephrine. in addition, tte will be used to measure the cardiac output to calibrate the ppv measurements.

Eligibility criteria:
inclusion criteria: * adult * patients scheduled for diep flap surgery exclusion criteria: * unwilling or unable to grant written informed consent * contra-indications for phenylephrine or norepinephrine * cardiac arrhythmia * no necessity for pharmacological blood pressure management

Keywords: cardiac output pulse pressure variation fluid responsiveness hemodynamic monitoring
repetitive transcranial magnetic stimulation to promote regeneration in persons with sci

Conditions: Spinal Cord Injuries

Summary: this is a research study to evaluate the safety, efficacy and feasibility of high-frequency repetitive transcranial magnetic stimulation (hf-rtms) in patients with subacute spinal cord injury.

this research study is investigating whether repetitive high-frequency transcranial magnetic stimulation (hf-rtms) in patients with subacute spinal cord injury is safe, efficacious, and feasible. the study will take approximately 7-8 months to complete, during which 15 training sessions with hf-rtms will be completed. followed by 30 minutes each session of arm and hand training without hf-rtms. the participants will complete testing after the 15 training sessions as well as 6 months following completion.

Eligibility criteria:
inclusion criteria: * be less than 8 weeks post injury * must have an incomplete spinal cord injury at a neurological level of injury between the c2-c6 level and an impairment grade a, b, c, or d, according to the american spinal injury association (asia) impairment scale * if an outpatient, will be at least 6 months post injury exclusion criteria: * have a pacemaker * have metal in the skull * have a history of seizures, or a brain injury * being pregnant * have skin issues or open wounds * have severe contractures and/or spasms in my elbow/wrists as determined by study staff examination at screening * study staff will review medications to determine if taking any drugs that would increase risk of having a seizure while undergoing tms. if taking such medications, will not be enrolled
glucolipotoxicity and type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory function of the pancreas. this is known as glucolipotoxicity. however, few studies have examined this in detail. this investigation will examine pancreatic insulin secretory function in physiological models of glucolipotoxicity such as obese and type 2 diabetic individuals. furthermore, healthy subjects will undergo 24 hour infusion of glucose or intralipid to induce experimental models of glucolipotoxicity. insulin secretion in response to intravenous infusions of glucose, glp-1, gip, and arginine and in response to meal ingestion, will be examined. the investigators hypothesize that experimental glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that seen in type 2 diabetics.


Eligibility criteria:
inclusion criteria: * normal glucose tolerance based on screening ogtt or * diagnosed type 2 diabetic (confirmed with ogtt) exclusion criteria: * insulin dependent diabetes * age \ 65 years * bmi \ 35 kg/m2 * evidence of hematological, pulmonary, hepatic, renal, or cardiovascular disease * actively undergoing weight-loss (\>2kg change in last 6 months) * bariatric surgery (gastric by-pass or banding) * pregnancy * smoking

Keywords: diabetes incretin beta-cell function glucolipotoxicity glucagon-like peptide 1 glucose-dependent insulinotropic polypeptide
hemodynamic and respiratory effects of esophageal dilation in children

Conditions: Obstruction of Esophagus; Respiratory Complication; Hemodynamic Instability

Summary: the aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.

esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. emerging strictures are dilated with balloon catheter at regular intervals. the possibility of various complications depending on the level of the stenosis during the dilation of esophagus. during esophageal dilation may be pressed into airways and/or vascular structure.

Eligibility criteria:
inclusion criteria: * endoscopy for esaphageal dilatation and control * asa i-iii * 0-16 year old exclusion criteria: * asa iv * endoscopy for removing foreing body